An observational study in Mitral Regurgitation and Heart Failure, sponsored by University of Athens. Completed at 1 site in Greece. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2020-01-06.
Sponsored by University of Athens · Observational
The aim of this study is i) to evaluate left ventricular global longitudinal strain and myocardial work in patients with heart failure and severe functional mitral regurgitation one year after MitraClip implantation and compare these variables with patients treated with optimal medical treatment and ii) to find echocardiographic predictors of clinical response and reverse left ventricular remodeling at one-year follow up.
This study is one of the first in terms of publication. As far as the investigators know there are few papers with small series of patients regarding echocardiographic parameters and strain imaging in patients with functional mitral regurgitation (MR) and MitraClip. As the investigator's goal is to assess the potential impact of the MitraClip on myocardial deformation indexes, at the end of the study a direct comparison of changes of echocardiography markers -at one year follow up- between the control and device group will be performed. The changes in myocardial deformation markers will be associated with the respective changes in Brain-natriuretic peptide (BNP) levels, New York Heart Association (NYHA) class status, 6-minute walking distance (6MWD) and left ventricle (LV) volumes at follow -up. The investigators also aim to identify baseline prognostic echocardiography markers for the prediction of clinical improvement and LV reverse remodeling after successful edge-to-edge repair in functional MR patients during one year follow up. In specific, in this study the investigators will measure the 2-Dimension (2D) strain values of the left ventricle and left atrium (global longitudinal strain-GLS of the LV and Peak Atrial longitudinal strain - PALS of the left atrium) at baseline and at one year follow up, they will appreciate the LV myocardial work and all its components (Global Work Index-GWI, Global Constructed Work-GCW,Global wasted work-GWW and Global Work Efficiency-GWE) of the left ventricle and finally they will evaluate the baseline variables as predictors of reverse LV remodeling defined by reduction of left ventricle end-diastolic and end-systolic volume at one-year follow up.
459 studies on the registry are indexed under Mitral Valve Insufficiency; 148 are open to participants now.
This study's enrollment of 100 is below the median of 154 across 167 observational studies indexed under Mitral Valve Insufficiency.
Browse Mitral Valve Insufficiency studies →University of Athens is the lead sponsor of 133 studies on the registry; 19 are open to participants now.
Counted across the registry records on this site, refreshed daily.
heart failure patients with severe functional mitral regurgitation that are treated either with MitraClip or with optimal medical treatment
Exclusion Criteria:
patients with heart failure and concomitant severe functional mitral regurgitation that were treated with MitraClip
Diagnostic Test: speckle tracking analysis of transthoracic echocardiogram
patients with heart failure and concomitant severe functional mitral regurgitation that were treated with optimal medical treatment
Diagnostic Test: speckle tracking analysis of transthoracic echocardiogram
analysis at workstation with 2D strain-Speckle tracking echocardiography of transthoracic cardiac echo at baseline and one-year follow up examination
Changes of LV volumes
change of left ventricular end-diastolic and end-systolic volumes during one-year follow up of the patients
Time frame: one year
Changes of NYHA class status
measurement of NYHA class status at baseline and one-year follow uo
Time frame: one year
Changes of myocardial work of the LV
Evaluation of the components of myocardial work (Global work index, global constructive work, Global wasted Work and Global Work efficiency) at baseline and one-year follow up
Time frame: one year
Plan to share: Undecided
This study is completed, as verified in Jan 2020. You cannot join it, but the record below documents what was studied.
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University of Athens